BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20DP VENTED IV DC 15 MICRON

    MDR report key: 17476779 · Received August 7, 2023

    Report

    Report Number
    9616066-2023-01664
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    May 24, 2023
    Report Date
    August 11, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, MDR MFR# 9616066-2023-01664 WAS SUBMITTED IN ERROR; THIS PRODUCT IS EXEMPT FROM US FDA REPORTING REQUIREMENTS. PLEASE CONSIDER MDR MFR# 9616066-2023-01664 VOID. THE DEVICE IS MANUFACTURED IN A FACILITY THAT DOES NOT MANUFACTURE DEVICES FOR THE US MARKET. THESE DEVICES ARE SOLD OUTSIDE OF THE US AND ARE NOT SIMILAR TO BD DEVICES REGISTERED OR SOLD IN THE US.

    Additional Manufacturer Narrative · 0

    D.4 DEVICE EXPIRATION DATE: UNKNOWN. D.4. MEDICAL DEVICE LOT #: LOT 568644 AND 568751 WAS REPORTED; HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG # 4378B. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 20DP VENTED IV DC 15 MICRON EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: FORM: WHEN THE NURSE WAS GOING TO CONNECT THE SET TO THE INFUSION FLUID, THE TUBE CAME LOOSE FROM THE DRIP CHAMBER. REK 23-2544 CHAMBER REF (B)(4) BATCH 568644 (PCS USE IN BATCH 0722263 164) BATCH 568751(PCS USE IN BATCH 0722263 2836 PCS) RECEIVED FROM BD AND USE FOR OUR SETS QTY PCS 87.000.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 20DP VENTED IV DC 15 MICRON EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: FORM: WHEN THE NURSE WAS GOING TO CONNECT THE SET TO THE INFUSION FLUID, THE TUBE CAME LOOSE FROM THE DRIP CHAMBER. REK 23-2544 CHAMBER REF (B)(4), BATCH 568644 (PCS USE IN BATCH 0722263 164) BATCH 568751(PCS USE IN BATCH 0722263 2836 PCS) RECEIVED FROM BD AND USE FOR OUR SETS QTY PCS 87.000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466836 20DP VENTED IV DC 15 MICRON INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown